Increasing the odds of effective drug development: Elevating regulatory affairs professionals to strategic partners. (1st October 2016)

• Record Type: Journal Article
• Authors: Drago, Daniela; Yap, Markus; Ekmekci, Ozgur
• Is Part Of: Clinical research and regulatory affairs. Volume 33:Number 2/4(2016)
• Page Start: 59
• Page End: 65
• Publication Date: 2016-10-01
• Subjects: Regulatory strategy -- regulatory education -- competencies; Pharmacy -- Research -- Periodicals; Pharmacy -- Law and legislation -- Periodicals; Drugs -- Testing -- Periodicals; Pharmaceutical industry -- Periodicals; 615.10724
• DOI: 10.3109/10601333.2016.1152661
• Languages: English
• ISSNs: 1060-1333

Abstract

Abstract: In today's globalized drug development landscape, the need for regulatory professionals to be more seamlessly integrated into strategic decisions is evident. Whereas a few companies see the benefit of involving regulatory affairs professionals in strategic business decisions, many still lag behind. Limited literature and scholarly discussion is available on whether regulatory affairs professionals are given the stature and power to make a meaningful contribution during strategy formulation across all stages of the product development, launch, and life-cycle management. This article examines the current business environment for the regulated industries; discusses why it is important that regulatory affairs play an active and strategic role in this sector; and proposes a new educational perspective to facilitate the recognition and acceptance of regulatory affairs professionals as strategic partners.